Implant having multiple adjustment mechanisms

ABSTRACT

A method is provided for use with an implant structure, a first tool, a second tool, and a longitudinal guide member. The implant structure is delivered to a heart of a subject, the implant structure including: (i) a first adjustment mechanism to which the first tool is coupled, and (ii) a second adjustment mechanism to which the longitudinal guide member is coupled. The implant structure is then coupled to tissue of the heart. Subsequently, the second tool is advanced along the longitudinal guide member to the second adjustment mechanism.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a Continuation of U.S. patent applicationSer. No. 14/990,172 to Miller et al., filed Jan. 7, 2016, whichpublished as US 2016/0113767 (now U.S. Pat. No. 9,775,709), and which isa Continuation of U.S. patent application Ser. No. 14/486,226 to Milleret al., filed Sep. 15, 2014, and entitled “Implant having multiplerotational assemblies,” which published as US 2015/0012087 (now U.S.Pat. No. 9,265,608), and which is a Continuation of U.S. patentapplication Ser. No. 13/666,262 to Miller et al, filed Nov. 1, 2012, andentitled “Implant having multiple rotational assemblies”, whichpublished as US 2013/0116780 (now U.S. Pat. No. 8,858,623), and whichclaims priority from U.S. Provisional Application 61/555,570, filed onNov. 4, 2011, which are each incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates in general to valve repair. Morespecifically, the present invention relates to repair of a mitral valveof a patient.

BACKGROUND

Mitral regurgitation (MR), mitral insufficiency or mitral incompetenceis a disorder of the heart in which the mitral valve does not closeproperly when the heart pumps out blood. It is the abnormal leaking ofblood from the left ventricle, through the mitral valve, and into theleft atrium, when the left ventricle contracts, i.e. there isregurgitation of blood back into the left atrium. MR is the most commonform of valvular heart disease.

In functional mitral valve regurgitation (FMR), otherwise known asSecondary mitral regurgitation is characterized as the abnormal functionof anatomically normal valve, i.e., the papillary muscles, chordae, andvalve leaflets are otherwise normal. Regurgitation, the result ofincomplete closure of normal leaflets occurs in a quarter of patientsafter myocardial infarction and up to 50% of those with heart failure.

FMR can be either due to ischemia and any cause of dilated leftventricle including, annular enlargement secondary to left ventriculardilatation, or papillary muscle displacement due to left ventricularremodeling, which results in tethering and excess tenting of the mitralvalve leaflets.

Severe FMR is indicative of poor hemodynamics and typically a badprognosis for the patient.

SUMMARY OF THE INVENTION

In some applications of the present invention, apparatus is providedcomprising an implant structure comprising an adjustable annuloplastyring structure coupled to at least first and second adjustingmechanisms, each comprising a respective rotatable structure. At least aportion of the annuloplasty ring structure comprises a flexible,longitudinally-compressible segment (e.g., coiled structures, stent-likestruts, and/or a braided mesh). The annuloplasty structure is shaped todefine a flexible, tubular body portion that is shaped so as to define alumen thereof that houses at least one flexible longitudinal contractingmember. The at least one flexible longitudinal contracting member iscoupled to the first adjusting mechanism at a first portion of theflexible longitudinal contracting member. A second portion of theflexible longitudinal contracting member is coupled to a portion of thetubular body portion. The first adjusting mechanism is configured toadjust a perimeter of the annuloplasty ring structure by adjusting adegree of tension of the flexible member housed within the lumen of theannuloplasty structure. For example, the first adjusting mechanism isconfigured to contract the ring structure in response to rotation in afirst rotational direction of the rotational structure of the firstadjusting mechanism. The first adjusting mechanism is typically alignedwith the tubular body portion.

Typically, the annuloplasty structure is configured to be implantedalong a native annulus of an atrioventricular valve of a patient.

For some applications of the present invention, the second adjustingmechanism is coupled to an outer surface of the tubular body portion.The second adjusting mechanism is coupled to a first portion of aflexible longitudinal tension member. The flexible longitudinal tensionmember is configured to pass from the annuloplasty ring structure on theannulus of the valve of and into a ventricle. A second portion of theflexible longitudinal tension member is coupled to a tissue-engagingelement configured to engage cardiac tissue in a vicinity of theventricle (e.g., a portion of papillary muscle tissue, a portion oftissue of an inner wall of the ventricle, or a portion of tissue of anouter wall of the ventricle). For some applications, the tissue-engagingelement comprises a sharp portion for penetrating the cardiac tissue.For some applications, the tissue-engaging element comprises a planarelement abutting against tissue of the patient. Typically, the secondportion of the flexible longitudinal tension member is configured to becoupled to a papillary muscle of the patient. The second adjustingmechanism is configured to adjust a degree of tension of the flexiblelongitudinal tension member in a manner sufficient to (a) adjust aposition of the papillary muscle, (b) adjust a degree of distension ofthe ventricular wall, and/or (c) have the flexible longitudinal tensionmember function as an artificial chordae tendineae. For applications inwhich the position of the papillary muscle is adjusted such positioningtypically provides therapy to the patient.

For some applications of the present invention, an annuloplasty ringstructure comprises two or more adjusting mechanisms configured to shapethe annuloplasty ring structure into a desired shape. For example, thetwo or more adjusting mechanisms function, upon actuation thereof, toform the adjustable ring into a saddle shape. Alternatively oradditionally, the two or more adjusting mechanisms function, uponactuation thereof, to draw together opposing portions of the ring.

Typically, the annuloplasty ring structures described herein, theadjusting mechanisms, and the flexible longitudinal members are advancedand implanted in an open-heart procedure. For some applications, devicesdescribed herein may be implanted using a minimally-invasive orpercutaneous transcatheter procedure.

Methods for delivery and use of the invention are also described.

There is therefore provided, in accordance with an application of thepresent invention, apparatus for use with a native valve of a heart of apatient, the native valve having a valve annulus, and the heart having aventricle, the apparatus including:

an annuloplasty structure, shaped to define a perimeter, and configuredto be disposed at the annulus of the native valve of the patient;

a first adjusting mechanism, coupled to the annuloplasty structure, andconfigured to adjust the perimeter of the annuloplasty structure;

at least one longitudinal flexible member, having a first end portion,and a second end portion that is configured to be coupled to tissue ofthe ventricle of the heart of the patient; and

at least a second adjusting mechanism:

-   -   coupled to the annuloplasty structure such that the second        adjusting mechanism is slidable around at least part of the        perimeter of the annuloplasty structure,    -   coupled to the first end portion of the at least one        longitudinal flexible member, and    -   configured to adjust a distance between the second adjusting        mechanism and the second end portion of the at least one        longitudinal flexible member.

In an application:

the annuloplasty structure is configured to be implanted at an annulusof a mitral valve of the patient,

the at least second adjusting mechanism is configured to be coupled to alocation along the annulus, in a vicinity of a fibrous trigone adjacentto the mitral valve.

In an application, the apparatus further includes a plurality ofsutures, each suture of the plurality of sutures being configured to befastened to a respective location along a circumference of an annulus ofa mitral valve of the patient, the plurality of sutures being configuredto facilitate advancement of the annuloplasty structure toward theannulus.

In an application, the annuloplasty structure includes a coiledstructure having a lumen.

In an application, the annuloplasty structure includes a partialannuloplasty ring.

In an application, the annuloplasty structure includes a fullannuloplasty ring.

In an application, the annuloplasty structure is coated withpolytetrafluoroethylene.

In an application, the annuloplasty structure has a first end and asecond end, and a longitudinal axis therebetween, and the secondadjusting mechanism is movable along the longitudinal axis of theannuloplasty structure.

In an application, the annuloplasty structure includes a body portionthat defines a lumen therethrough, and the annuloplasty structurefurther includes a flexible longitudinal contracting member, having afirst end portion, a second end portion, and a middle portion betweenthe first and second end portions, at least one of the end portionsbeing coupled to the first adjusting mechanism, and the middle portionbeing disposed within the lumen of the body portion.

In an application, the first adjusting mechanism is configured toreversibly adjust the perimeter of the annuloplasty structure, and thesecond adjusting mechanism is configured to reversibly adjust thedistance.

In an application, the second adjusting mechanism is configured toadjust the distance between the second adjusting mechanism and thesecond end portion of the at least one longitudinal flexible member,independently of the adjusting of the perimeter of the annuloplastystructure by the first adjusting mechanism.

In an application:

the at least one longitudinal flexible member includes a firstlongitudinal flexible member and a second longitudinal flexible member,the first and second longitudinal members each having a first endportion and a second end portion, the second portion of the firstlongitudinal flexible member being configured to be coupled to a firstportion of the tissue, and the second portion of the second longitudinalflexible member being configured to be coupled to a second portion ofthe tissue,

the second adjusting mechanism is coupled to the first end portion ofthe first longitudinal flexible member, and is configured to adjust adistance between the second adjusting mechanism and the second endportion of the first longitudinal flexible member,

the apparatus further includes a third adjusting mechanism, coupled tothe annuloplasty structure and to the first end portion of the secondlongitudinal flexible member, and is configured to adjust a distancebetween the third adjusting mechanism and the second end portion of thesecond longitudinal flexible member.

In an application:

at least one selected from the group consisting of the first portion ofthe tissue and the second portion of the tissue, includes tissue of apapillary muscle of the patient, and

at least one selected from the group consisting of the second adjustingmechanism and the third adjusting mechanism, is configured to adjust adistance between the papillary muscle and the annuloplasty structure.

In an application, the third adjusting mechanism is configured to adjustthe distance between the third adjusting mechanism and the second endportion of the second longitudinal flexible member, independently of theadjustment, by the second adjusting mechanism, of the distance betweenthe second adjusting mechanism and the second end portion of the firstlongitudinal flexible member.

In an application, the first adjusting mechanism includes a firstrotatable adjusting mechanism, and the second adjusting mechanismincludes a second rotatable adjusting mechanism.

In an application, the first rotatable adjusting mechanism and thesecond rotatable adjusting mechanism are both rotatable bidirectionally.

In an application, the second rotatable adjusting mechanism includes aspool, and the spool is configured to pull the tissue toward theannuloplasty structure, via the longitudinal flexible member,responsively to rotation of the spool.

In an application, the apparatus further includes a rotation tool,configured to rotate the first rotatable adjusting mechanism.

In an application, the rotation tool includes an elongate rotation tool,configured to extend from outside the patient, to the first rotatableadjusting mechanism.

In an application, the rotation tool is configured to facilitateadjustment of the first adjusting mechanism while the heart of thepatient is beating.

In an application, the rotation tool includes a first rotation tool, andthe apparatus further includes a second rotation tool, configured torotate the second rotatable adjusting mechanism.

In an application, at least the first adjusting mechanism includes alocking mechanism:

having an unlocked state in which the first adjusting mechanism isadjustable, having

having a locked state in which the locking mechanism inhibits adjustmentof the first adjusting mechanism, and

configured to be intracorporeally moved from the locked state to theunlocked state.

In an application, the first rotation tool is configured tointracorporeally move the first rotatable adjusting mechanism into theunlocked configuration thereof.

In an application, the tissue includes papillary muscle tissue of thepatient, and apparatus is configured to relocate the papillary muscletissue, by pulling the papillary muscle tissue toward the annuloplastystructure.

In an application:

the annuloplasty structure is configured to be implanted at an annulusof a mitral valve of the patient, and

the longitudinal flexible member is configured to relocate the papillarymuscle tissue, in response to the pulling by the adjusting mechanism.

In an application, the longitudinal flexible member is configured toperform a therapy by relocating the patient's papillary muscle tissue.

In an application, the annuloplasty structure is configured to beimplanted at an annulus of a mitral valve of the patient, and theapparatus is configured to be transcatheterally advanced toward theannulus.

In an application, the apparatus is configured to be transluminallyadvanced toward the annulus.

In an application, the second end portion of the longitudinal flexiblemember includes a tissue-coupling element.

In an application, the tissue-coupling element includes an anchor havingat least one sharp portion.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve of a heart of apatient, the native valve having a valve annulus, and the heart having aventricle, the apparatus including:

an annuloplasty structure, shaped to define a perimeter, and configuredto be disposed at the annulus of the native valve of the patient;

a first adjusting mechanism, coupled to the annuloplasty structure, andconfigured to reversibly adjust the perimeter of the annuloplastystructure;

at least one longitudinal flexible member, having a first end portion,and a second end portion that is configured to be coupled to tissue ofthe ventricle of the heart of the patient; and

at least a second adjusting mechanism, coupled to the annuloplastystructure and to the first end portion of the at least one longitudinalflexible member, and configured to reversibly adjust a distance betweenthe second adjusting mechanism and the second end portion of the atleast one longitudinal flexible member.

In an application, the annuloplasty structure has a first end and asecond end, and a longitudinal axis therebetween, and the secondadjusting mechanism is movable along the longitudinal axis of theannuloplasty structure.

In an application, the annuloplasty structure includes a body portionthat defines a lumen therethrough, and the annuloplasty, structurefurther includes a flexible longitudinal contracting member, having afirst end portion, a second end portion, and a middle portion betweenthe first and second end portions, at least one of the end portionsbeing coupled to the first adjusting mechanism, and the middle portionbeing disposed within the lumen of the body portion.

In an application, the first adjusting mechanism is movably coupled tothe annuloplasty structure.

In an application, the annuloplasty structure includes a partialannuloplasty ring.

In an application, the annuloplasty structure includes a fullannuloplasty ring.

In an application, the annuloplasty structure is coated withpolytetrafluoroethylene.

In an application:

the annuloplasty structure is configured to be implanted at an annulusof a mitral valve of the patient,

the at least second adjusting mechanism is configured to be coupled to alocation along the annulus, in a vicinity of a fibrous trigone adjacentto the mitral valve.

In an application, the apparatus further includes a plurality ofsutures, each suture of the plurality of sutures being configured to befastened to a respective location along a circumference of an annulus ofa mitral valve of the patient, the plurality of sutures being configuredto facilitate advancement of the annuloplasty structure toward theannulus.

In an application, the annuloplasty structure includes a coiledstructure having a lumen.

In an application, the second adjusting mechanism is configured toreversibly adjust the distance between the second adjusting mechanismand the second end portion of the at least one longitudinal flexiblemember, independently of the reversible adjusting of the perimeter ofthe annuloplasty structure by the first adjusting mechanism.

In an application:

the at least one longitudinal flexible member includes a firstlongitudinal flexible member and a second longitudinal flexible member,the first and second longitudinal members each having a first endportion and a second end portion, the second portion of the firstlongitudinal flexible member being configured to be coupled to a firstportion of the tissue, and the second portion of the second longitudinalflexible member being configured to be coupled to a second portion ofthe tissue,

the second adjusting mechanism is coupled to the first end portion ofthe first longitudinal flexible member, and is configured to reversiblyadjust a distance between the second adjusting mechanism and the secondend portion of the first longitudinal flexible member,

the apparatus further includes a third adjusting mechanism, coupled tothe annuloplasty structure and to the first end portion of the secondlongitudinal flexible member, and is configured to reversibly adjust adistance between the third adjusting mechanism and the second endportion of the second longitudinal flexible member.

In an application:

at least one selected from the group consisting of the first portion ofthe tissue and the second portion of the tissue, includes tissue of apapillary muscle of the patient, and

at least one selected from the group consisting of the second adjustingmechanism and the third adjusting mechanism, is configured to reversiblyadjust a distance between the papillary muscle and the annuloplastystructure.

In an application, the third adjusting mechanism is configured toreversibly adjust the distance between the third adjusting mechanism andthe second end portion of the second longitudinal flexible member,independently of the reversible adjustment, by the second adjustingmechanism, of the distance between the second adjusting mechanism andthe second end portion of the first longitudinal flexible member.

In an application, the first adjusting mechanism includes a firstrotatable adjusting mechanism, and the second adjusting mechanismincludes a second rotatable adjusting mechanism.

In an application, the first rotatable adjusting mechanism and thesecond rotatable adjusting mechanism are both rotatable bidirectionally.

In an application, the second rotatable adjusting mechanism includes aspool, and the spool is configured to pull the tissue toward theannuloplasty structure, via the longitudinal flexible member,responsively to rotation of the spool.

In an application, the apparatus further includes a rotation tool,configured to rotate the first rotatable adjusting mechanism.

In an application, the rotation tool includes an elongate rotation tool,configured to extend from outside the patient, to the first rotatableadjusting mechanism.

In an application, the rotation tool is configured to facilitatereversible adjustment of the first adjusting mechanism while the heartof the patient is beating.

In an application, the rotation tool includes a first rotation tool, andthe apparatus further includes a second rotation tool, configured torotate the second rotatable adjusting mechanism.

In an application, at least the first adjusting mechanism includes alocking mechanism:

having an unlocked state in which the first adjusting mechanism isadjustable, having

having a locked state in which the locking mechanism inhibits adjustmentof the first adjusting mechanism, and

configured to be intracorporeally moved from the locked state to theunlocked state.

In an application, the first rotation tool is configured tointracorporeally move the first rotatable adjusting mechanism into theunlocked configuration thereof.

In an application, the tissue includes papillary muscle tissue of thepatient, and apparatus is configured to relocate the papillary muscletissue, by pulling the papillary muscle tissue toward the annuloplastystructure.

In an application:

the annuloplasty structure is configured to be implanted at an annulusof a mitral valve of the patient, and

the longitudinal flexible member is configured to relocate the papillarymuscle tissue, in response to the pulling by the adjusting mechanism.

In an application, the longitudinal flexible member is configured toperform a therapy by relocating the patient's papillary muscle tissue.

In an application, the annuloplasty structure is configured to beimplanted at an annulus of a mitral valve of the patient, and theapparatus is configured to be transcatheterally advanced toward theannulus.

In an application, the apparatus is configured to be transluminallyadvanced toward the annulus.

In an application, the second end portion of the longitudinal flexiblemember includes a tissue-coupling element.

In an application, the tissue-coupling element includes an anchor havingat least one sharp portion.

There is further provided, in accordance with an application of thepresent invention, a method for use with a native valve of a heart of apatient, the native valve having a valve annulus, and the heart having aventricle, the method including:

adjusting a dimension of the annulus by rotating a first adjustingmechanism of apparatus that has been implanted in the heart of thepatient;

adjusting a first distance between a first portion of tissue of theventricle of the patient and the annulus by rotating a second adjustingmechanism of the apparatus; and

subsequently to the adjusting of the first distance, adjusting a seconddistance between a second portion of tissue of the ventricle of thepatent and the annulus by rotating a third adjusting mechanism of theapparatus.

In an application, the annuloplasty structure has a first end and asecond end, and a longitudinal axis therebetween, and sliding the secondadjusting mechanism includes sliding the second adjusting mechanismalong the longitudinal axis of the annuloplasty structure.

In an application:

the annuloplasty structure includes a body portion that defines a lumentherethrough, and a flexible longitudinal contracting member, having afirst end portion, a second end portion, and a middle portion betweenthe first and second end portions, at least one of the end portionsbeing coupled to the first adjusting mechanism, and the middle portionbeing disposed within the lumen of the body portion, and

adjusting the perimeter of the annuloplasty structure includes adjustinga length of the flexible longitudinal contracting member between thefirst end portion of the flexible longitudinal contracting member andthe second end portion of the flexible longitudinal contracting member.

In an application, coupling the annuloplasty structure to the annulusincludes coupling the annuloplasty structure to an annulus of a mitralvalve of the patient such that the at least second adjusting mechanismis disposed in a vicinity of a fibrous trigone adjacent to the mitralvalve.

In an application, the method further includes receiving informationindicative of blood flow of the patent, subsequently to the adjusting ofthe first distance, and prior to the adjusting of the second distance.

In an application, the method further includes receiving informationindicative of blood flow in the heart of the patient, subsequently tothe adjusting of the dimension of the annulus, and prior to theadjusting of the first distance.

In an application, at least one of: (1) the adjusting of the dimensionof the annulus, (2) the adjusting of the first distance, and (3) theadjusting of the second distance, include adjusting while the heart isbeating.

In an application, adjusting the first adjusting mechanism includesadjusting the first adjusting mechanism while the heart of the patientis beating.

In an application, adjusting the at least second adjusting mechanismincludes adjusting the at least second adjusting mechanism while theheart of the patient is beating.

In an application, coupling the second end portion to the first portionof the tissue of the ventricle includes coupling the second end portionto tissue of a papillary muscle of the patient.

In an application, the method further includes adjusting a dimension ofthe annulus by adjusting the first adjusting mechanism.

In an application, the method further includes adjusting a distancebetween the annulus and the tissue, by adjusting the second adjustingmechanism.

In an application, the method further includes adjusting a dimension ofthe annulus by adjusting the first adjusting mechanism, and adjusting adistance between the annulus and the tissue independently of theadjustment of the dimension of the annulus, by adjusting the secondadjusting mechanism independently of the adjustment of the firstadjusting mechanism.

In an application, coupling the second end portion to the tissueincludes rotating an anchor coupled to the second end portion.

In an application, at least one selected from the group consisting ofadjusting the first adjusting mechanism and adjusting the secondadjusting mechanism, includes rotating a rotatable adjusting mechanism.

In an application, at least one action selected from the groupconsisting of adjusting the first adjusting mechanism and adjusting thesecond adjusting mechanism, includes reversibly adjusting.

In an application, coupling the annuloplasty structure to the annulusincludes coupling a partial annuloplasty ring to the annulus.

In an application, coupling the annuloplasty structure to the annulusincludes coupling a full annuloplasty ring to the annulus.

In an application, at least one action selected from the groupconsisting of adjusting the first adjusting mechanism and adjusting thesecond adjusting mechanism, includes adjusting using a rotation tool.

In an application, using the rotation tool includes using an elongaterotation tool that extends from outside the patient, to the apparatus.

In an application, the method further includes, prior to adjusting,performing at least one action selected from the group consisting ofunlocking the first adjustment mechanism using the rotation tool, andunlocking the second adjustment mechanism using the rotation tool.

In an application, the method further includes transcatheterallyadvancing the annuloplasty structure to the native valve.

In an application, transcatheterally advancing the annuloplastystructure to the native valve includes transluminally advancing theannuloplasty structure to the native valve.

In an application, the annuloplasty structure is coupled to a thirdadjusting mechanism that is coupled to a first end portion of a secondlongitudinal flexible member, and the method further includes coupling asecond end portion of the second longitudinal member to a second portionof the tissue of the ventricle.

In an application, the method further includes adjusting a distancebetween the annuloplasty structure and the second portion of the tissueby adjusting the third adjusting mechanism.

There is further provided, in accordance with an application of thepresent invention, a method for use with a native valve of a heart of apatient, the native valve having a valve annulus, and the heart having aventricle, the method including:

while the heart is beating, using apparatus that has been implanted inthe heart:

-   -   reducing a dimension of the annulus,    -   reducing a distance between the annulus and at least a first        portion of tissue of the ventricle of the patient, and    -   subsequently, increasing at least one selected from the list        consisting of: the dimension, and the distance; and

receiving information indicative of blood flow of the patient, thereducing and the increasing of the dimension and the distance being atleast in part responsive to the receiving of the information.

In an application:

reducing the dimension includes rotating a first adjusting mechanism ofthe apparatus in a first rotational direction, and increasing thedimension includes rotating the first adjusting mechanism in a second,opposing rotational direction, and

reducing the distance includes rotating at least a second adjustingmechanism of the apparatus in a first rotational direction, andincreasing the distance includes rotating the second adjusting mechanismin a second, opposing rotational direction.

There is further provided, in accordance with an application of thepresent invention, a method for use with a native valve of a heart of apatient, the native valve having a valve annulus, and the heart having aventricle, the method including:

coupling, to the annulus, an annuloplasty structure, shaped to define aperimeter, and coupled to:

-   -   a first adjusting mechanism, configured to adjust the perimeter        of the annuloplasty structure, and    -   at least a second adjusting mechanism, configured to be slidable        around at least part of the perimeter of the annuloplasty        structure, and coupled to a first end portion of at least one        longitudinal flexible member;

coupling, to at least a first portion of tissue of the ventricle of theheart, a second end portion of the at least one longitudinal flexiblemember; and

sliding the second adjusting mechanism around at least part of the atleast part of the perimeter of the annuloplasty structure.

In an application, the annuloplasty structure has a first end and asecond end, and a longitudinal axis therebetween, and sliding the secondadjusting mechanism includes sliding the second adjusting mechanismalong the longitudinal axis of the annuloplasty structure.

In an application:

the annuloplasty structure includes a body portion that defines a lumentherethrough, and a flexible longitudinal contracting member, having afirst end portion, a second end portion, and a middle portion betweenthe first and second end portions, at least one of the end portionsbeing coupled to the first adjusting mechanism, and the middle portionbeing disposed within the lumen of the body portion, and

adjusting the perimeter of the annuloplasty structure includes adjustinga length of the flexible longitudinal contracting member between thefirst end portion of the flexible longitudinal contracting member andthe second end portion of the flexible longitudinal contracting member.

In an application, coupling the annuloplasty structure to the annulusincludes coupling the annuloplasty structure to an annulus of a mitralvalve of the patient such that the at least second adjusting mechanismis disposed in a vicinity of a fibrous trigone adjacent to the mitralvalve.

In an application, coupling the annuloplasty structure to the annulusincludes coupling a partial annuloplasty ring to the annulus.

In an application, coupling the annuloplasty structure to the annulusincludes coupling a full annuloplasty ring to the annulus.

In an application, adjusting the first adjusting mechanism includesadjusting the first adjusting mechanism while the heart of the patientis beating.

In an application, adjusting the at least second adjusting mechanismincludes adjusting the at least second adjusting mechanism while theheart of the patient is beating.

In an application, coupling the second end portion to the first portionof the tissue of the ventricle includes coupling the second end portionto tissue of a papillary muscle of the patient.

In an application, the method further includes adjusting a dimension ofthe annulus by adjusting the first adjusting mechanism.

In an application, the method further includes adjusting a distancebetween the annulus and the tissue, by adjusting the second adjustingmechanism.

In an application, the method further includes adjusting a dimension ofthe annulus by adjusting the first adjusting mechanism, and adjusting adistance between the annulus and the tissue independently of theadjustment of the dimension of the annulus, by adjusting the secondadjusting mechanism independently of the adjustment of the firstadjusting mechanism.

In an application, coupling the second end portion to the tissueincludes rotating an anchor coupled to the second end portion.

In an application, at least one selected from the group consisting ofadjusting the first adjusting mechanism and adjusting the secondadjusting mechanism, includes rotating a rotatable adjusting mechanism.

In an application, at least one action selected from the groupconsisting of adjusting the first adjusting mechanism and adjusting thesecond adjusting mechanism, includes reversibly adjusting.

In an application, at least one action selected from the groupconsisting of adjusting the first adjusting mechanism and adjusting thesecond adjusting mechanism, includes adjusting using a rotation tool.

In an application, using the rotation tool includes using an elongaterotation tool that extends from outside the patient, to the apparatus.

In an application, the method further includes, prior to adjusting,performing at least one action selected from the group consisting ofunlocking the first adjustment mechanism using the rotation tool, andunlocking the second adjustment mechanism using the rotation tool.

In an application, the method further includes transcatheterallyadvancing the annuloplasty structure to the native valve.

In an application, transcatheterally advancing the annuloplastystructure to the native valve includes transluminally advancing theannuloplasty structure to the native valve.

In an application, the annuloplasty structure is coupled to a thirdadjusting mechanism that is coupled to a first end portion of a secondlongitudinal flexible member, and the method further includes coupling asecond end portion of the second longitudinal member to a second portionof the tissue of the ventricle.

In an application, the method further includes adjusting a distancebetween the annuloplasty structure and the second portion of the tissueby adjusting the third adjusting mechanism.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve of a heart of apatient, the native valve having a valve annulus, and the heart having aventricle, the apparatus including:

an annuloplasty structure, shaped to define a perimeter, and configuredto be disposed at the annulus of the native valve of the patient;

a first adjusting mechanism, coupled to the annuloplasty structure, andconfigured to adjust the perimeter of the annuloplasty structure;

at least one longitudinal flexible member, having a first end portion,and a second end portion that is configured to be coupled to tissue ofthe ventricle of the heart of the patient; and

at least a second adjusting mechanism, coupled to the annuloplastystructure and to the first end portion of the at least one longitudinalflexible member, and configured to adjust a distance between the secondadjusting mechanism and the second end portion of the at least onelongitudinal flexible member,

the first and second adjusting mechanisms each including a respectivelocking mechanism, each locking mechanism:

-   -   having an unlocked state in which the respective adjusting        mechanism is adjustable, having    -   having a locked state in which the locking mechanism inhibits        adjustment of the respective adjusting mechanism, and    -   configured to be intracorporeally moved from the locked state to        the unlocked state.

In an application, the annuloplasty structure includes a partialannuloplasty ring.

In an application, the annuloplasty structure includes a fullannuloplasty ring.

In an application, the annuloplasty structure is coated withpolytetrafluoroethylene.

In an application:

the annuloplasty structure is configured to be implanted at an annulusof a mitral valve of the patient,

the at least second adjusting mechanism is configured to be coupled to alocation along the annulus, in a vicinity of a fibrous trigone adjacentto the mitral valve.

In an application, the apparatus further includes a plurality ofsutures, each suture of the plurality of sutures being configured to befastened to a respective location along a circumference of an annulus ofa mitral valve of the patient, the plurality of sutures being configuredto facilitate advancement of the annuloplasty structure toward theannulus.

In an application, the annuloplasty structure includes a coiledstructure having a lumen.

In an application, the annuloplasty structure has a first end and asecond end, and a longitudinal axis therebetween, and the secondadjusting mechanism is movable along the longitudinal axis of theannuloplasty structure.

In an application, the annuloplasty structure includes a body portionthat defines a lumen therethrough, and the annuloplasty structurefurther includes a flexible longitudinal contracting member, having afirst end portion, a second end portion, and a middle portion betweenthe first and second end portions, at least one of the end portionsbeing coupled to the first adjusting mechanism, and the middle portionbeing disposed within the lumen of the body portion.

In an application, the first adjusting mechanism is movably coupled tothe annuloplasty structure.

In an application, the first adjusting mechanism is configured toreversibly adjust the perimeter of the annuloplasty structure, and thesecond adjusting mechanism is configured to reversibly adjust thedistance.

In an application, the second adjusting mechanism is configured toadjust the distance between the second adjusting mechanism and thesecond end portion of the at least one longitudinal flexible member,independently of the adjusting of the perimeter of the annuloplastystructure by the first adjusting mechanism.

In an application:

the at least one longitudinal flexible member includes a firstlongitudinal flexible member and a second longitudinal flexible member,the first and second longitudinal members each having a first endportion and a second end portion, the second portion of the firstlongitudinal flexible member being configured to be coupled to a firstportion of the tissue, and the second portion of the second longitudinalflexible member being configured to be coupled to a second portion ofthe tissue,

the second adjusting mechanism is coupled to the first end portion ofthe first longitudinal flexible member, and is configured to adjust adistance between the second adjusting mechanism and the second endportion of the first longitudinal flexible member,

the apparatus further includes a third adjusting mechanism, coupled tothe annuloplasty structure and to the first end portion of the secondlongitudinal flexible member, and is configured to adjust a distancebetween the third adjusting mechanism and the second end portion of thesecond longitudinal flexible member.

In an application:

at least one selected from the group consisting of the first portion ofthe tissue and the second portion of the tissue, includes tissue of apapillary muscle of the patient, and

at least one selected from the group consisting of the second adjustingmechanism and the third adjusting mechanism, is configured to adjust adistance between the papillary muscle and the annuloplasty structure.

In an application, the third adjusting mechanism is configured to adjustthe distance between the third adjusting mechanism and the second endportion of the second longitudinal flexible member, independently of theadjustment, by the second adjusting mechanism, of the distance betweenthe second adjusting mechanism and the second end portion of the firstlongitudinal flexible member.

In an application, the first adjusting mechanism includes a firstrotatable adjusting mechanism, and the second adjusting mechanismincludes a second rotatable adjusting mechanism.

In an application, the first rotatable adjusting mechanism and thesecond rotatable adjusting mechanism are both rotatable bidirectionally.

In an application, the second rotatable adjusting mechanism includes aspool, and the spool is configured to pull the tissue toward theannuloplasty structure, via the longitudinal flexible member,responsively to rotation of the spool.

In an application, the apparatus further includes a rotation tool,configured to rotate the first rotatable adjusting mechanism.

In an application, the rotation tool includes an elongate rotation tool,configured to extend from outside the patient, to the first rotatableadjusting mechanism.

In an application, the rotation tool is configured to facilitateadjustment of the first adjusting mechanism while the heart of thepatient is beating.

In an application, the rotation tool includes a first rotation tool, andthe apparatus further includes a second rotation tool, configured torotate the second rotatable adjusting mechanism.

In an application, the first rotation tool is configured tointracorporeally move the first rotatable adjusting mechanism into theunlocked configuration thereof, and the second rotation tool isconfigured to intracorporeally move the second rotatable adjustingmechanism into the unlocked configuration thereof.

In an application, the tissue includes papillary muscle tissue of thepatient, and apparatus is configured to relocate the papillary muscletissue, by pulling the papillary muscle tissue toward the annuloplastystructure.

In an application:

the annuloplasty structure is configured to be implanted at an annulusof a mitral valve of the patient, and

the longitudinal flexible member is configured to relocate the papillarymuscle tissue, in response to the pulling by the adjusting mechanism.

In an application, the longitudinal flexible member is configured toperform a therapy by relocating the patient's papillary muscle tissue.

In an application, the annuloplasty structure is configured to beimplanted at an annulus of a mitral valve of the patient, and theapparatus is configured to be transcatheterally advanced toward theannulus.

In an application, the apparatus is configured to be transluminallyadvanced toward the annulus.

In an application, the second end portion of the longitudinal flexiblemember includes a tissue-coupling element.

In an application, the tissue-coupling element includes an anchor havingat least one sharp portion.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve of a heart of apatient, the native valve having a valve annulus, and the heart having aventricle, the apparatus including:

an annuloplasty structure, configured to be disposed at the annulus ofthe native valve of the patient, and shaped to define a perimeter;

a perimeter-adjusting mechanism, coupled to the annuloplasty structure,and configured to adjust the perimeter of the annuloplasty structure;and

at least two longitudinal flexible members, each longitudinal flexiblemember having a first end portion and a second end portion, the secondend portion of each longitudinal flexible member being configured to becoupled to a respective portions of tissue of a ventricle of the heartof the patient; and

at least two length-adjusting mechanisms, each being coupled to theannuloplasty structure and to the first end portion of a respectivelongitudinal flexible member, and configured to adjust a distancebetween the length-adjusting mechanism and the second end portion of therespective longitudinal flexible member, independently of the adjustmentof the perimeter of the annuloplasty structure by the first adjustingmechanism.

In an application:

the at least two length-adjusting mechanisms include a firstlength-adjusting mechanism and a second length-adjusting mechanism,

the at least two longitudinal flexible members include a firstlongitudinal flexible member and a second longitudinal flexible member,

the first length-adjusting mechanism is coupled to the first end portionof the first longitudinal flexible member, and is configured to adjustthe distance between the first length-adjusting mechanism and the secondend portion of the first longitudinal flexible member, and

the second length-adjusting mechanism is coupled to the first endportion of the second longitudinal flexible member, and is configured toadjust a distance between the second length-adjusting mechanism and thesecond end portion of the second longitudinal flexible member,independently of the adjustment, by the first length-adjusting member,of a distance between the first length-adjusting mechanism and thesecond end portion of the first longitudinal flexible member.

In an application, at least one of the length-adjusting mechanisms ismovable around at least part of the perimeter of the annuloplastystructure.

In an application, the annuloplasty structure includes a body portionthat defines a lumen therethrough, and the annuloplasty structurefurther includes a flexible longitudinal contracting member, having afirst end portion, a second end portion, and a middle portion betweenthe first and second end portions, at least one of the end portionsbeing coupled to the first adjusting mechanism, and the middle portionbeing disposed within the lumen of the body portion.

There is further provided, in accordance with an application of thepresent invention, a method, including:

providing an annuloplasty structure, the annuloplasty structureincluding:

-   -   at least one adjusting mechanism couplable to the annuloplasty        structure; and    -   at least one longitudinal flexible member;

coupling the annuloplasty structure to an annulus of a mitral valve of apatient;

coupling the longitudinal flexible member to a portion of tissue; and

relocating the portion of tissue toward the annulus by pulling thetissue with the adjusting mechanism, via the longitudinal flexiblemember.

In an application, coupling the longitudinal flexible member to theportion of tissue includes coupling the longitudinal flexible member topapillary muscle tissue.

In an application, the annuloplasty structure includes two adjustingmechanisms, each adjusting mechanism configured to relocate respectiveportions of tissue, and coupling the annuloplasty structure to theannulus includes:

coupling a first one of the adjusting mechanisms to a first locationalong the annulus in a vicinity of a first fibrous trigone of the mitralvalve; and

coupling a second one of the adjusting mechanisms to a second locationalong the annulus in a vicinity of a second fibrous trigone of themitral valve.

In an application, the method further includes transcatheterallyadvancing the annuloplasty structure to the annulus.

In an application, coupling the annuloplasty structure to the annulusincludes coupling the annuloplasty structure to the annulus during openheart surgery.

In an application, the method further includes:

rotating, in a first direction, a rotatable adjusting mechanism that iscoupled to the annuloplasty structure, by pulling a contracting memberthat is coupled to the rotatable structure; and

responsively, drawing first and second portions of the annuloplastystructure toward each other.

The present invention will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of an annuloplasty structure coupledto at least first and second adjusting mechanisms, in accordance withsome applications of the present invention;

FIGS. 2A-B are schematic illustrations of an adjustable annuloplastystructure coupled to adjusting mechanisms that are slidable with respectto the adjustable annuloplasty structure, in accordance with someapplications of the present invention;

FIG. 3 is a schematic illustration of an adjusting mechanism, inaccordance with some applications of the present invention;

FIG. 4 is a schematic illustration of another adjusting mechanism, inaccordance with some applications of the present invention;

FIG. 5 is a schematic illustration of another annuloplasty structurecoupled to at least first and second adjusting mechanisms, in accordancewith some applications of the present invention;

FIGS. 6A-B, 7A-B, and 8A-B are schematic illustrations of placing theimplant structure of FIG. 1 in a heart of a patient, in accordance withsome applications of the present invention;

FIGS. 9A-B are schematic illustrations of an implant structurecomprising a septo-lateral adjusting mechanism, in accordance with someapplications of the present invention;

FIGS. 10A-B are schematic illustrations an implant structure comprisinga plurality of adjusting mechanisms which shape the structure into asaddle-shaped ring, in accordance with some applications of the presentinvention; and

FIG. 11 is a schematic illustration of a system for providinginformation indicative of heart function of the patient, and forfacilitating adjusting the adjusting mechanisms of an annuloplastystructure in response to the information, in accordance with someapplications of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is now made to FIG. 1, which is a schematic illustration of asystem 120 comprising an implant structure 122 which comprises anadjustable annuloplasty ring structure that is coupled to two or moreflexible-longitudinal-tension-member-adjusting-mechanisms 240 (e.g.,flexible-longitudinal-tension-member-adjusting-mechanisms 240 a and 240b), in accordance with some applications of the present invention. Forsome applications, as shown, the annuloplasty ring structure comprises afull annuloplasty ring. Adjusting mechanisms 240 a and 240 b typicallycomprise rotatable structures (e.g., spools, as described hereinbelow)which are coupled to respective first portions of flexible longitudinaltension members 60 a and 60 b. When system, 120 is implanted in theheart of the patient, implant structure 122 is configured to beimplanted at an annulus of a native valve of a patient (e.g., anatrioventricular valve such as the mitral valve or the tricuspid valve).Tension members 60 a and 60 b are configured to extend toward theventricle of the heart of the patient by passing between the leaflets ofthe valve or by passing through tissue of the annulus or commissures ofthe valve. Respective second end portions of tension members 60 a and 60b are configured to be coupled to respective portions of cardiac tissuewhich are in the vicinity of the ventricle of the heart (e.g., portionsof papillary muscle, portions of tissue at the base of the papillarymuscle, portions of tissue in a vicinity of the apex, portions of tissueof an inner wall of the ventricle, and/or portions of tissue of an outerwall of the ventricle). Rotation of the rotatable structures ofmechanisms 240 a and 240 b in a first rotational direction pulls tightthe respective tension members 60 a and 60 b in order to draw theportions of cardiac tissue toward implant structure 122 (i.e., byreducing a distance between each mechanism 240 and the second endportion of the respective tension member 60). Rotation of the rotatablestructures in a second, opposing, rotational direction loosens therespective tension members. For some applications of the presentinvention, system 120 functions to repair and/or effect remodeling ofthe portions of cardiac tissue, remodeling of the papillary muscles,and/or remodeling of a heart wall of the ventricle to treat distension.For some applications, tension members function as artificial chordaetendineae.

Flexible tension members 60 a and 60 b comprise a wire, a ribbon, arope, or a band, comprising a flexible metal. Typically, flexibletension members 60 a and 60 b comprise a flexible and/or superelasticmaterial, e.g., nitinol, polyester, stainless steel, or cobalt chrome.In some applications of the present invention, flexible tension members60 a and 60 b each comprise a braided polyester suture (e.g., Ti-Cron™).In some applications of the present invention, flexible contractingmembers 60 a and 60 b are coated with polytetrafluoroethylene (PTFE). Insome applications of the present invention, flexible tension member 60 aand 60 b each comprise a plurality of wires that are intertwined to forma rope structure.

Typically, but not necessarily, each of adjusting mechanisms 240 a and240 b is coupled to a respective longitudinal guide member 86 a and 86b. Distal end portions of each guide member 86 a and 86 b are coupled torespective portions of mechanisms 240 a and 240 b and facilitate guidingalong members 86 a and 86 b of a rotational tool toward the rotatablestructures of mechanisms 240 a and 240 b.

The annuloplasty structure of implant structure 122 is shaped to definea flexible, tubular body portion 24 that is shaped so as to define alumen along a longitudinal axis of structure 122 that houses at leastpart of at least one flexible longitudinal contracting member 30 (e.g.,a middle portion of member 30). At least a portion, e.g., the entirety,of body portion 24 comprises a compressible material (e.g., a coiledelement 12), as shown by way of illustration and not limitation. Forexample, body portion 24 may comprise stent-like struts, or a braidedmesh (independently of coiled portion 12). Typically, coiled element 12is surrounded by a braided mesh 10.

Typically, body portion 24 comprises a flexible biocompatible material,e.g., nitinol, stainless steel, platinum iridium, titanium, expandedpolytetrafluoroethylene (ePTFE), or cobalt chrome. In some applicationsof the present invention, body portion 24 is coated with PTFE(Polytetrafluoroethylene). In other applications of the presentinvention, body portion 24 comprises accordion-like compressiblestructures which facilitate proper cinching of the annulus whenstructure 122 is contracted. Body portion 24, when compressed, e.g.,typically along a longitudinal axis of structure 122, enables portionsof annuloplasty structure 122 to contract and independently conform tothe configuration of the annulus of the mitral valve of a given subject.Thus, the compressible element of body portion 24 facilitatescontraction of the annulus in response to contraction of structure 122.

The annuloplasty structure of implant structure 122 comprises aflexible-longitudinal-contracting-member-adjusting-mechanism 40 disposedwithin a housing 44 and coupled to contracting member 30 (as describedhereinbelow with reference to FIG. 3). Adjusting mechanism 40 isconfigured to adjust a degree of tension of contracting member 30 inorder to adjust a perimeter of implant structure 122. Adjustingmechanism 40 thereby acts as a perimeter-adjusting mechanism. Housing 44of adjusting mechanism 40 is shaped so as to define first and secondcoupling members 31 and 35 (shown in FIG. 3). Body portion 24 has firstand second ends 21 and 23 which are coupled to first and second couplingmembers 31 and 35, and thereby to adjusting mechanism 40, in order tocreate a full annuloplasty ring. Thus, adjusting mechanism 40 is alignedwith body portion 24 along the longitudinal axis thereof.

Adjusting mechanisms 240 a and 240 b are coupled to an outer surface ofbody portion 24, as shown. Typically, mechanisms 240 a and 240 b arecoupled via sutures or any other mechanical coupling, as describedhereinbelow with reference to FIGS. 2A-B. Typically, for applications inwhich structure 122 is implanted on the annulus of a mitral valve,adjusting mechanism 240 a is coupled to a portion of the annuloplastystructure in a vicinity thereof that is configured to be placed on ornear a left fibrous trigone of the annulus of the mitral valve of thepatient, and adjusting mechanism 240 b is coupled to a portion of theannuloplasty structure in a vicinity thereof that is configured to beplaced on or near a right fibrous trigone of the annulus of the mitralvalve of the patient.

Flexible contracting member 30 comprises a wire, a ribbon, a rope, or aband, comprising a flexible metal. Flexible contracting member 30 iscoupled at a first end portion thereof toflexible-longitudinal-contracting-member-adjusting-mechanism 40 which iscoupled to a first end 21 of body portion 24. A second end portion offlexible contracting member 30 is coupled to a second end 23 of bodyportion 24. Typically, during a resting state of structure 122, flexiblecontracting member 30 (e.g., the middle portion thereof) is disposed inparallel with the longitudinal axis of structure 122. Flexible member30, for some applications does not comprise a continuous band that runsthrough the entire lumen of the annuloplasty devices described herein,and flexible member 30 has at least one free end portion.

Typically, flexible contracting member 30 comprises a wire, a cable, ora rope, and taken together with the compressible element of body portion24 and the braided mesh surrounding body portion 24, imparts flexibilityto the entire annuloplasty structure.

Typically, flexible contracting member 30 comprises a flexible and/orsuperelastic material, e.g., nitinol, polyester, stainless steel, orcobalt chrome, and is configured to reside chronically within structure122. In some applications of the present invention, flexible contractingmember 30 comprises a braided polyester suture (e.g., Ti-Cron™). In someapplications of the present invention, flexible contracting member 30 iscoated with polytetrafluoroethylene (PTFE). In some applications of thepresent invention, flexible contracting member 30 comprises a pluralityof wires that are intertwined to form a rope structure.

Adjusting mechanism 40 comprises a housing 44 which houses a rotatablestructure, or a spool 46. The rotatable structure is rotatable in firstand second opposing rotational directions with respect to housing 44 soas to expand and contract the annuloplasty structure, respectively.Spool 46 has a cylindrical body that is disposed perpendicularly withrespect to the longitudinal axis of structure 122. As shown in FIG. 3,spool 46 is shaped to provide at least one hole 42 for coupling of thefirst end portion of flexible contracting member 30 thereto and,thereby, to adjusting mechanism 40. For some applications of the presentinvention, spool 46 is shaped to define one or more holes 42 configuredfor looping a portion of contracting member 30 therethrough, asdescribed hereinbelow. In such an application: (a) a middle portion,which defines the first end portion, of contracting member 30 is coupledto spool 46 by being looped through one or more holes 42, (b) first andsecond portions that extend from the first end portion looped throughspool 46 extend toward second end 23 of structure body portion 24, and(c) first and second free ends of contracting member 30 are coupled tosecond end 23 of body portion 24 and define a second end portion ofcontracting member 30.

It is to be noted that for some applications of the present invention,flexible contracting member 30 may be coupled at both its first andsecond end portions, e.g., first and second ends, to spool 46 ofadjusting mechanism 40. In some applications of the present invention, afirst end of flexible contracting member 30 is coupled to spool 46 whilea second end of flexible contracting member 30 is coupled to the housingwhich houses spool 46. For some applications, contracting member 30comprises a continuous band that is looped through a portion of spool46.

As shown, the annuloplasty structure of implant structure 122 defines asubstantially ring-shaped configuration, e.g., a “D”-shapedconfiguration, as shown, which conforms to the shape of the annulus of amitral valve of the subject. For applications in which structure 122 isimplanted at a tricuspid valve of the patient, the annuloplastystructure assumes a shape suitable to fit the tricuspid valve (e.g., asubstantially oval shape).

Prior to contracting of structure 122, the compressible element of bodyportion 24 is relaxed and structure 122 defines a first perimeterthereof. Structure 122 provides portions 49 which are flexible and lesslongitudinally compressible, e.g., not longitudinally compressible, withrespect to the compressible element of body portion 24. Portions 49 areconfigured to be disposed along the fibrous portion of the annulus thatis between the fibrous trigones of the mitral valve of the heart whenstructure 122 is anchored, sutured, fastened or otherwise coupled to theannulus of the mitral valve. Portions 49 impart rigidity to structure122 in the portion thereof that is disposed between the fibrous trigonessuch that structure 122 better mimics the conformation and functionalityof the mitral valve. That is, during rotation of spool 46, and theconcurrent contraction or expansion of structure 122, energy is notexpended on contracting or expanding portions 49. As shown, coiledportion 12 of body portion 24 has a very small pitch compared to coiledportion 12 in the remaining portions of the annuloplasty structure. Forsome applications, portions 49 comprise a material that is arranged in aconfiguration in which portions 49 are more rigid.

Typically, both portions 49 have a combined length of 10-50 mm.

Thus, the annuloplasty structure of implant structure 122 defines acompressible portion and a non-compressible portion. Typically, a radiusof curvature at a center of the compressible portion of body portion 24is smaller than a radius of curvature at a center of less-compressibleportions 49, when no external force is applied to the annuloplastystructure.

It is to be noted that the compressible element of body portion 24 andless-compressible portions 49 comprise flexible coiled elements by wayof illustration and not limitation. For example, the compressibleelement of body portion 24 and less-compressible portions 49 maycomprise stent-like struts, or a braided mesh. In either configuration,portions 49 are chronically longitudinally compressed in a resting stateof structure 122.

It is to be noted that, structure 122 may be provided independently ofless-compressible portions 49. In such applications of the presentinvention, the annuloplasty structure comprises a fully compressiblering, e.g., a continuous ring.

It is to be noted that housing 44 (and mechanism 40) may be disposed atany suitable location along structure 122, and not only in betweenportions 49 (e.g., in a portion of the annuloplasty structure designatedfor implantation at an anterior portion of the mitral valve). Forexample, housing 44 may be coupled to the section of body portion 24that is compressible. In some applications of the present invention,housing 44 may be disposed in the middle of the section of body portion24 that is compressible. In some applications of the present invention,housing 44 may be coupled to structure 122 at an interface between afirst end of portion 49 and the section of body portion 24 that iscompressible. In such applications of the present invention, portions 49may be combined to form one substantially less-compressible portionhaving first and second ends that are in series with the compressibleportion of body portion 24. For some applications, a plurality ofhousings and adjusting mechanisms 40 described herein may be coupled tothe annuloplasty structure. Each adjusting mechanism 40 may be coupledto a respective contracting member 30 which controls a respectiveportion of the annuloplasty structure.

Typically, the annuloplasty structure of implant structure 122 isdelivered to the annulus of the valve using an elongate tool 50 that isreversibly coupled to adjusting mechanism 40 of structure 122. Tool 50comprises an elongate body portion 52 which houses a flexible rod thatis coupled at a distal end thereof to a screwdriver head. Thescrewdriver head is configured to be disposed within the channel ofspool 46. Typically, the rod functions as a screwdriver which appliesforce to the screwdriver head in order to rotate spool 46, and therebyfacilitate contraction of structure 122.

For some applications, the screwdriver head comprises force applicator88, as described hereinabove with reference to FIG. 3. For otherapplications, force applicator 88 is coupled to an elongate member thatis removable from spool 46 by tool 50.

(In this context, in the specification and in the claims, “proximal”means closer to the orifice through which the implant structure isoriginally placed into the body of the patient, along the path ofdelivery of the implant structure, and “distal” means further from thisorifice along the path of delivery of the implant structure.)

In some applications of the present invention, the annuloplastystructure is wrapped around an annuloplasty sizer 121. Once wrappedaround sizer 121, the flexible member is contracted by tool 50 such thatthe annuloplasty structure hugs and is stabilized around sizer 121.Sizer is coupled to a shaft 123. (It is to be noted that, for clarity ofillustration, tool 50, body portion 52, and shaft 123 are not shown inthe enlarged portion of FIG. 1.) Tool 50, shaft 123, and sizer 121 helpposition implant structure 122 along the annulus and stabilize thestructure as it is being contracted. Once the structure 122 ispositioned at the annulus, structure is sutured, anchored, or otherwisecoupled to the annulus. Following the coupling of structure 122 to theannulus, sizer 121 is decoupled from structure 122.

Subsequently, tool 50 facilitates the contraction and/or expansion ofthe annuloplasty structure of implant structure 122 in order to adjust adimension of the valve annulus. The distal portion of tool 50 comprisesa tool housing which surrounds a portion of housing 44 of mechanism 40,and stabilizes housing 44 during the advancement and contraction and/orexpansion of structure 122.

Reference is now made to FIGS. 2A-B, which are schematic illustrationsof a system 130, which is similar to system 120, as describedhereinabove with reference to FIG. 1, with the exception that adjustingmechanisms 240 a and 240 b are coupled to body portion 24 of theannuloplasty structure of implant structure 122 by a slide-facilitatingring 241, in accordance with some applications of the present invention.Housing 248 of each adjusting mechanism 240 is coupled to ring 241, asshown in FIG. 2A. Ring 241 surrounds a portion of the outer surface ofbody portion 24 and enables mechanism 240 to slide along the outersurface of body portion 24 to any suitable position along theannuloplasty structure of implant structure 122 (as indicated by thearrow and the adjusting mechanism 240 shown in phantom in FIG. 2B).

It is to be noted that adjusting mechanisms 240 are shown in FIGS. 2A-Bwithout guide members 86 (described hereinabove with reference to FIG.1).

Reference is now made to FIG. 3, which is a schematic illustrationshowing a relationship among individual components offlexible-longitudinal-contracting-member-adjusting-mechanism 40, inaccordance with some applications of the present invention. Adjustingmechanism 40 is shown as comprising spool housing 44 which defines anupper surface 45 and a recess 142 at a lower surface thereof. A spool 46is configured to be disposed within housing 44 and defines an uppersurface 150, a lower surface 180, and a cylindrical body portiondisposed vertically between surfaces 150 and 180. The cylindrical bodyportion of spool 46 is shaped so as to define a channel which extendsfrom a first opening at upper surface 150 to a second opening at lowersurface 180.

Lower surface 180 of spool 46 is shaped to define one or more (e.g., aplurality, as shown) of recesses 182 which define structural barrierportions 188 of lower surface 180. It is to be noted that any suitablenumber of recesses 182 may be provided, e.g., between 1 and 10 recesses.For some applications, recesses 182 are provided circumferentially withrespect to lower surface 180 of spool 46.

Typically, spool 46 comprises a locking mechanism 145. For someapplications, locking mechanism 145 is coupled, e.g., welded, at leastin part to a lower surface of spool housing 44. Typically, lockingmechanism 145 defines a mechanical element having a planar surface thatdefines slits 58. The surface of locking mechanism 145 may also becurved, and not planar. Locking mechanism 145 is shaped to provide aprotrusion 156 which projects out of a plane defined by the planarsurface of the mechanical element. The slits define a depressibleportion 128 of locking mechanism 145 that is disposed in communicationwith and extends toward protrusion 156.

In a resting state of locking mechanism 145 (i.e., a locked state ofspool 46), protrusion 156 is disposed within a recess 182 of spool 46.Additionally, in the locked state of spool 46, protrusion 156 isdisposed within recess 142 of housing 44.

Depressible portion 128 is aligned with the opening at lower surface 180of spool 46 and is moveable in response to a force applied thereto by adistal force applicator 88. That is, distal force applicator 88 isconfigured to be disposed within the channel of spool 46. A distal endof applicator 88 is configured to push on depressible portion 128 inorder to move depressible portion 128 downward so as to disengageprotrusion 156 from within a recess 182 of spool and to unlock spool 46from locking mechanism 145.

It is to be noted that the planar, mechanical element of lockingmechanism 145 is shown by way of illustration and not limitation andthat any suitable mechanical element having or lacking a planar surfacebut shaped to define at least one protrusion may be used together withlocking mechanism 145.

A cap 1044 is provided that is shaped so as to define a planar surfaceand an annular wall having an upper surface 244 that is coupled to,e.g., welded to, the lower surface of spool housing 44. The annular wallof cap 1044 is shaped so as to define a recessed portion 1144 of cap1044 that is in alignment with recess 142 of spool housing 44. Lockingmechanism 145 is disposed between lower surface 180 of spool 46 and theplanar surface of cap 1044.

In an unlocked state of adjusting mechanism 40, protrusion 156 oflocking mechanism 145 is disposed within recessed portion 1144 of cap1044. In the unlocked state, force applicator 88 extends through spool46 and pushes against depressible portion 128 of locking mechanism 145.The depressible portion is thus pressed downward, freeing protrusion 156from within a recess 182 defined by structural barrier portions 188 ofthe lower portion of spool 46. Additionally, protrusion 156 is freedfrom within the recessed portion of spool housing 44. As a result,contracting mechanism 40 is unlocked, and spool 46 may be rotated withrespect to spool housing 44.

Cap 1044 functions to restrict distal pushing of depressible portion 128beyond a desired distance so as to inhibit deformation of lockingmechanism 145. For applications in which adjusting mechanism 40 isimplanted in heart tissue, cap 1044 also provides an interface betweenadjusting mechanism 40 and the heart tissue. This prevents interferenceof heart tissue on adjusting mechanism 40 during the locking andunlocking thereof. Additionally, cap 1044 prevents damage to hearttissue by depressible portion 128 as it is pushed downward.

Spool 46 is shaped so as to define a driving interface 48. A rotationtool (not shown) is configured to slide engage spool 46 at interface 48.The rotation tool is configured to rotate spool 46 by applyingrotational force to spool 46 at interface 48. For some applications, afriction-reducing ring (not shown in FIG. 3, but shown in FIG. 4) isdisposed between upper surface 150 of spool 46 and the inner surface ofupper surface 45 of spool housing 44.

For some applications the rotation tool used to rotate spool 46 may beshaped to provide distal force applicator 88 configured to unlock spool46 from locking mechanism 145. When unlocked, spool 46 may bebidirectionally rotated.

Following rotation of spool 46 such that contraction member 30 iscontracted sufficiently to adjust the perimeter of the annuloplastystructure to a desired dimension so as to contract the annulus of thevalve, spool 46 is then locked in place so as to restrict rotation ofspool 46. Force applicator 88 is removed from within the channel ofspool 46, and thereby, depressible portion 128 returns to its restingstate. As depressible portion 128 returns to its resting state,protrusion 156 is introduced within one of the plurality of recesses 182of lower surface 180 of spool 46 and within recess 142 of housing 44,and thereby restricts rotation of spool 46.

Reference is now made to FIG. 4, which is a schematic illustrationshowing a relationship among individual components offlexible-longitudinal-tension-member-adjusting-mechanism 240, inaccordance with some applications of the present invention. Adjustingmechanism 240 is shown as comprising spool housing 248 which defines anupper surface 160 and a lower surface 176 defining a recessed portion(as described with regard to recess 142 with reference to FIG. 3). Aspool 246 is configured to be disposed within housing 248 and defines anupper surface 178, a lower surface 180, and a cylindrical body portiondisposed vertically between surfaces 178 and 180. The cylindrical bodyportion of spool 246 is shaped so as to define a channel which extendsfrom a first opening at upper surface 178 to a second opening at lowersurface 180.

Lower surface 180 of spool 246 is shaped to define one or more (e.g., aplurality, as shown) of recesses 182 which define structural barrierportions 188 of lower surface 180. It is to be noted that any suitablenumber of recesses 182 may be provided, e.g., between 1 and 10 recesses.For some applications, recesses 182 are provided circumferentially withrespect to lower surface 180 of spool 246.

Typically, spool 246 comprises a locking mechanism 145. For someapplications, locking mechanism 145 is coupled, e.g., welded, at leastin part to a lower surface of spool housing 248. Typically, lockingmechanism 145 defines a mechanical element having a planar surface thatdefines slits 58. The surface of locking mechanism 145 may also becurved, and not planar. Locking mechanism 145 is shaped to provide aprotrusion 156 which projects out of a plane defined by the planarsurface of the mechanical element. The slits define a depressibleportion 128 of locking mechanism 145 that is disposed in communicationwith and extends toward protrusion 156.

In a resting state of locking mechanism 145 (i.e., a locked state ofspool 246), protrusion 156 is disposed within a recess 182 of spool 246.Additionally, in the locked state of spool 246, protrusion 156 isdisposed within the recess of housing 248.

Depressible portion 128 is aligned with the opening at lower surface 180of spool 246 and is moveable in response to a force applied thereto by adistal force applicator 88 that extends in a distal direction from adistal portion of longitudinal guide member 86. That is, distal forceapplicator 88 is configured to be disposed within the channel of spool246. A distal end of applicator 88 is configured to push on depressibleportion 128 in order to move depressible portion 128 downward so as todisengage protrusion 156 from within a recess 182 of spool and to unlockspool 246 from locking mechanism 145.

It is to be noted that the planar, mechanical element of lockingmechanism 145 is shown by way of illustration and not limitation andthat any suitable mechanical element having or lacking a planar surfacebut shaped to define at least one protrusion may be used together withlocking mechanism 145.

A cap 1044 is provided that is shaped so as to define a planar surfaceand an annular wall having an upper surface 244 that is coupled to,e.g., welded to, lower surface 176 of spool housing 248. The annularwall of cap 1044 is shaped so as to define a recessed portion 1144 ofcap 1044 that is in alignment with the recessed portion of spool housing248. Locking mechanism 145 is disposed between lower surface 180 ofspool 246 and the planar surface of cap 1044.

In an unlocked state of adjusting mechanism 240, protrusion 156 oflocking mechanism 145 is disposed within recessed portion 1144 of cap1044. In the unlocked state, force applicator 88 extends through spool246 and pushes against depressible portion 128 of locking mechanism 145.The depressible portion is thus pressed downward, freeing protrusion 156from within a recess 182 defined by structural barrier portions 188 ofthe lower portion of spool 246. Additionally, protrusion 156 is freedfrom within the recessed portion of spool housing 248. As a result,contracting mechanism 240 is unlocked, and spool 246 may be rotated withrespect to spool housing 248.

Cap 1044 functions to restrict distal pushing of depressible portion 128beyond a desired distance so as to inhibit deformation of lockingmechanism 145. For applications in which adjusting mechanism 240 isimplanted in heart tissue, cap 1044 also provides an interface betweenadjusting mechanism 240 and the heart tissue. This prevents interferenceof heart tissue on adjusting mechanism 240 during the locking andunlocking thereof. Additionally, cap 1044 prevents damage to hearttissue by depressible portion 128 as it is pushed downward.

Spool 246 is shaped so as to define a rotation-facilitating head 170. Arotation tool (not shown) is configured to slide distally along guidemember 86 to engage head 170 of spool 246. The rotation tool isconfigured to rotate spool 246 by applying rotational force to head 170.A friction-reducing ring 172 is disposed between upper surface 178 ofspool 246 and the inner surface of upper surface 160 of spool housing248.

For some applications, as described herein, guide member 86 is notcoupled to spool 246. For such applications the rotation tool used torotate spool 246 may be shaped to provide a distal force applicator(similar to distal force applicator 88) configured to unlock spool 246from locking mechanism 145. In the unlocked state, spool 246 may bebidirectionally rotated.

Following rotation of spool 246 such that tension member 60 is pulledsufficiently to adjust the degree of tension of member 60 so as treattissue of the ventricle as described herein, spool 246 is then locked inplace so as to restrict rotation of spool 246. Force applicator 88 isremoved from within the channel of spool 246, and thereby, depressibleportion 128 returns to its resting state. As depressible portion 128returns to its resting state, protrusion 156 is introduced within one ofthe plurality of recesses 182 of lower surface 180 of spool 246 andwithin the recess of housing 248, and thereby restricts rotation ofspool 246.

Spool 246 is shaped so as to provide a hole 242 or other couplingmechanism for coupling a first portion of flexible longitudinal tensionmember 60 to spool 246, and thereby to adjusting mechanism 240.

FIG. 5 is a schematic illustration of a system 220 comprising an implantstructure 222 which comprises an adjustable annuloplasty ring structurethat is coupled to two or moreflexible-longitudinal-tension-member-adjusting-mechanisms 240 a and 240b, as described hereinabove with reference to FIG. 1, in accordance withsome applications of the present invention. For some applications, asshown, the annuloplasty ring structure comprises a partial annuloplastyring. Adjusting mechanisms 240 a and 240 b typically comprise rotatablestructures (e.g., spools, as described hereinbelow) which are coupled torespective first portions of flexible longitudinal tension members 60 aand 60 b. When system, 220 is implanted in the heart of the patient,implant structure 222 is configured to be implanted at an annulus of anative valve of a patient (e.g., an atrioventricular valve such as themitral valve or the tricuspid valve). Tension members 60 a and 60 b areconfigured to extend toward the ventricle of the heart of the patient bypassing between the leaflets of the valve or by passing through tissueof the annulus or commissures of the valve. Respective second endportions of tension members 60 a and 60 b are configured to be coupledto respective portions of cardiac tissue which are in the vicinity ofthe ventricle of the heart (e.g., portions of papillary muscle, portionsof tissue at the base of the papillary muscle, portions of tissue in avicinity of the apex, portions of tissue of an inner wall of theventricle, and/or portions of tissue of an outer wall of the ventricle).

Rotation of the rotatable structures of mechanisms 240 a and 240 b in afirst rotational direction pulls tight (e.g., shortens) the respectivetension members 60 a and 60 b in order to draw the portions of cardiactissue toward implant structure 222 (i.e., to reduce the distancebetween each mechanism 240 and the second end portion of the respectivetension member 60). Mechanisms 240 a and 240 b thereby act asperimeter-adjusting mechanisms. For some applications of the presentinvention, system 220 functions to repair and/or effect remodeling ofthe portions of cardiac tissue, remodeling of the papillary muscles,and/or remodeling of a heart wall of the ventricle to treat distension.For some applications, tension members function as artificial chordaetendineae.

Flexible-longitudinal-tension-member-adjusting-mechanisms 240 a and 240b, tension members 60 a and 60 b, contracting member 30, andflexible-longitudinal-contracting-member-adjusting-mechanism 40 shown inFIG. 4 are identical to those described hereinabove with reference toFIG. 1. For some applications, adjusting mechanisms 240 a and 240 b arecoupled to the outer surface of body portion 224 of structure 222 byrings 241, as described hereinabove with reference to FIGS. 2A-B. Theannuloplasty structure of implant structure 221 comprises a body portion224 which is similar to body portion 24 described hereinabove withreference to FIG. 1. It is to be noted that although body portion 224 isshown as comprising only coiled portion 12, body portion 224 maycomprise a braided mesh or may be surrounded by a braided mesh, asdescribed hereinabove with reference to FIG. 1.

Adjusting mechanism 40 is coupled to a first end 221 of body portion224. Flexible contracting member 30 is coupled at a first end portionthereof to adjusting mechanism 40. A second end portion of flexiblecontracting member 30 is coupled to a second end 223 of body portion224. Typically, during the resting state, flexible contracting member 30is disposed in parallel with the longitudinal axis of structure 222.That is, flexible member 30, for some applications does not comprise acontinuous band that runs through the entire lumen of the annuloplastydevices described herein, and flexible member 30 has at least one freeend portion.

Typically, first end 221 of body portion 224 is welded to couplingmember 31 of a housing 344 surrounding spool 46. Housing 344 is similarto housing 44 described herein, with the exception that coupling member35 of housing 44 is replaced with a first suture fastener 41. Firstsuture fastener 41 is shaped to define a hole 43 for passagetherethrough of a suture to suture structure 222 to tissue of thepatient. Second end 223 of body portion 224 comprises a second suturefastener 37 that is shaped to define a hole 47 for passage therethroughof a suture.

Reference is now made to FIGS. 1-3 and 5. As shown in FIG. 3, spool 46is shaped so as to provide one or more holes 42 a and 42 b or othercoupling mechanism for coupling a first portion of flexible longitudinalcontracting member 30 to spool 46, and thereby to adjusting mechanism40. In response to a rotational force applied to spool 46 in a firstrotational direction, successive portions of flexible contracting member30 are wrapped around spool 46 in order to tighten contracting member30. That is, during rotation of spool 46 in the first direction,successive portions of member 30 contact spool 46. As flexiblecontracting member 30 is wrapped around spool 46, the second end portionof member 30 is pulled toward adjusting mechanism 40. Pulling the secondend of flexible contracting member 30 toward mechanism 40 pulls therespective second ends 23 of structures 122 and 222 toward therespective first ends 21 of structures 122 and 222. Responsively, thecompressible element of body portion 24 is longitudinally compressed,thereby contracting structures 122 and 222.

It is to be noted that the contraction of structures 122 and 222 isreversible. That is, rotating spool 46 in a second rotational directionthat opposes the first rotational direction used to contract theannuloplasty structure, unwinds a portion of flexible contracting member30 from around spool 46. Unwinding the portion of flexible contractingmember 30 from around spool 46 thus feeds the portion of flexiblecontracting member 30 back into the lumen of body portion 24 ofrespective structures 122 and 222, thereby slackening the remainingportion of flexible contracting member 30 that is disposed within thelumen of body portion 24. Responsively, the annuloplasty structuregradually relaxes and expands (i.e., with respect to its contractedstate prior to the unwinding) as the compressible element of bodyportion 24 gradually expands.

Reference is now made to FIGS. 6A-B, which are schematic illustrationsof a system 300 for repairing a mitral valve 14 and papillary muscles 2a and 2 b of a heart 4 of the patient using implant structure 122, asdescribed hereinabove with reference to FIG. 1, in accordance with someapplications of the present invention. Implant structure 122 ispositioned along the annulus of valve 14 and is coupled thereto usingsutures, anchors, and/or any other suitable tissue-coupling element. Asshown, implant 122 is positioned along the annulus in a manner in whichportions 49 and mechanism 40 are disposed along the annulus at ananterior section 7 of valve 14, adjusting mechanism 240 a is implantedin a vicinity of a left fibrous trigone 8 of valve 14, and adjustingmechanism 240 b is implanted in a vicinity of a right fibrous trigone 5of valve 14. Following the coupling of structure 122 to the annulus ofvalve 14, tension members 60 a and 60 b are pulled down into a ventricle6 of heart 4 by the operating physician (e.g., using his/her hands orusing a tool). For some applications, members 60 a and 60 b pass throughan opening created in the annulus of valve 14 (e.g., by puncturing aneedle therethrough). Alternatively, members 60 a and 60 b pass betweenthe leaflets of valve 14. Further alternatively, members 60 a and 60 bpass through respective commissures of valve 14.

Respective tissue-coupling elements 302 a and 302 b are coupled torespective distal portions of members 60 a and 60 b, respectively.Elements 302 a and 302 b comprise helical tissue anchors by way ofillustration and not limitation. That is, elements 302 a and 302 b maycomprise any suitable tissue-engaging structure. As shown, elements 302a and 302 b are configured to be coupled to tissue of respectivepapillary muscles 2 a and 2 b.

Following the coupling of structure 122 to the annulus of valve 14and/or the coupling of tissue-engaging elements 302 a and 302 b, thespool of adjusting mechanism 40 is rotated in order to adjust adimension of the annuloplasty structure of implant structure 122 andthereby to adjust a dimension of the annulus and relative positioning ofthe leaflets of valve 14. For example, in response to rotation of thespool of mechanism 40 in a first rotational direction thereof, theannuloplasty structure is contracted in order to contract the annulusand to draw together the leaflets of valve 14.

Following the coupling of tissue-engaging elements 302 a and 302 b, thespools of adjusting mechanisms 240 a and 240 b are rotated in order toadjust a degree of tension of tension members 60 a and 60 b. Forexample, in response to rotation of the spools of mechanisms 240 a and240 b in a first rotational direction thereof, tension members 60 a and60 b are pulled tight in order to pull on papillary muscles 2 a and 2 b.

For such applications, members 60 a and 60 b function to relocate and/oralter a geometry and/or spatial configuration of papillary muscles 60 aand 60 b. For some applications, members 60 a and 60 b function asartificial chordae tendineae.

For some applications, members 60 a and 60 b function to repair adistension of the heart wall surrounding ventricle 6.

It is to be noted that implant structure 122 and tension members 60 aand 60 b may be implanted using an open-heart or minimally-invasiveprocedure.

For some applications, whether the implant structure and tension membersare implanted using an open-heart or a minimally-invasive procedure,adjustment (e.g., rotation) of mechanisms 40, 240 a, and 240 b isperformed off-pump (e.g., while the heart is beating), using a tool tofacilitate the rotation of the adjusting mechanisms (e.g., elongate tool50, force applicator 88, or similar). For example, following anopen-heart procedure, heart tissue may be closed so as to provide only asmall channel through which the tool extends, such that the heart canbeat without leaking. Adjustment (e.g., rotation) of the adjustingmechanisms off-pump facilitates adjustment of the valve annulus andventricle, while monitoring heart function and/or blood flow usingimaging techniques, e.g., such that the physician may adjust untiloptimal heart function and/or blood flow is attained. For example, thephysician may advance the tool (e.g., facilitated by imaging, such asfluoroscopy and/or ultrasound), and then sequentially, and/or repeatedlyadjust (e.g., rotate) mechanism 40, mechanism 240 a, and mechanism 240 b(e.g., facilitated by imaging, such as Doppler ultrasound, in real-timeand/or between adjustments). The order in which the adjusting mechanismsare adjusted may be decided by the physician, such as in response to theblood flow monitoring.

Reference is now made to FIGS. 7A-B, which are schematic illustrationsof a system 320 for repairing a mitral valve 14 and portions of tissueof ventricle 6 of a heart 4 of the patient, as described hereinabovewith reference to FIGS. 6A-B, with the exception that tissue-engagingelements 302 a and 302 b are coupled to respective portions of tissuealong an inner wall of ventricle 6, in accordance with some applicationsof the present invention. As shown, tissue-engaging element 302 a iscoupled to a portion 16 of tissue in a vicinity of an apex 17 of heart4, and tissue-engaging element 302 b is coupled to a portion 18 oftissue at a base of the papillary muscle.

For some applications, members 60 a and 60 b function to relocate and/oralter a geometry and/or spatial configuration of papillary muscles 60 aand 60 b. For other applications, members 60 a and 60 b function torepair a distension of the heart wall surrounding ventricle 6. For yetother applications, members 60 a and 60 b function as artificial chordaetendineae.

Reference is now made to FIGS. 8A-B, which are schematic illustrationsof a system 340 for repairing a mitral valve 14 and portions of tissueof ventricle 6 of a heart 4 of the patient, as described hereinabovewith reference to FIGS. 6A-B and 7A-B, with the exception thatrespective second portions of tension members 60 a and 60 b areconfigured to extend trans-myocardially to an external surface 19 ofheart 4, in accordance with some applications of the present invention.

A respective tissue-engaging element is coupled to the second portion ofeach tension member 60 a and 60 b. Each tissue-engaging elementcomprises a respective tissue-abutting pad 342 a and 342 b configured torest against respective portions of surface 19 of heart 4.

For such applications, members 60 a and 60 b function to repair adistension of the heart wall surrounding ventricle 6. For someapplications, members 60 a and 60 b function to relocate and/or alter ageometry and/or spatial configuration of papillary muscles 60 a and 60b.

Reference is now made to FIGS. 9A-B, which are schematic illustrationsof an implant structure 400 comprising an annuloplasty ring structure asdescribed hereinabove with reference to FIG. 1, with the exception thatstructure 400 comprises a proximity-adjusting-mechanism 420, inaccordance with some applications of the present invention. Structure400 defines an anterior-configured portion 402 configured for placementadjacent the anterior leaflet of the mitral valve. Additionally,structure 400 defines a posterior-configured portion 404 configured forplacement adjacent the posterior leaflet of the mitral valve. For someapplications, portion 402 is flexible and less longitudinallycompressible than portion 404. For example, portion 402 may compriseportions 49 described hereinabove with reference to FIG. 1.

As described hereinabove, adjusting mechanism 40 is configured to adjusta dimension of structure 400 by contracting and expanding a contractingmember disposed within the lumen of body portion 24.

As shown, flexible-longitudinal-contracting-member-adjusting-mechanism40 is aligned with body portion 24 along the longitudinal axis thereof,as described hereinabove with reference to FIG. 1.Proximity-adjusting-mechanism 420 comprises any rotatable adjustingmechanism described herein (e.g., as described hereinabove withreference to FIGS. 3 and 4). Mechanism 420 comprises a housing 426configured to surround a portion of the outer surface of body portion24, typically surrounding a portion of body portion 24 that opposesadjusting mechanism 40. The rotatable structure of proximity-adjustingmechanism 420 is coupled to a first portion of a flexible elongatemember 422. A second portion 424 of elongate member 422 is coupled tohousing 44 (e.g., typically at an external surface thereof).

Typically, the rotatable structure of adjusting mechanism 420 comprisesa spool. In response to rotation of the rotatable structure of adjustingmechanism 420 in a first rotational direction, successive portions ofelongate member 422 are wound around the spool and pull tight theportion of elongate member 422 disposed between adjusting mechanisms 40and 420. In response, a portion of posterior-configured portion 404 ispulled in the direction as indicated by the arrow in FIG. 9B. Thus,adjusting mechanism 420 is configured to adjust a septo-lateraldimension of structure 400 and of the annulus of the mitral valve whenstructure 400 is implanted at the annulus of the mitral valve in orderto adjust the distance between the leaflets of the valve and to adjustopposing portions of the annulus of the mitral valve.

It is to be noted that the rotation of the rotational structure ofadjusting mechanism 420 is reversible, and that following rotation ofthe rotatable structure in order to pull structure 400 into theconfiguration shown in FIG. 9B, the rotatable structure may be rotatedin a second rotational direction that opposes the first rotationaldirection in order for structure 400 to assume the configuration shownin FIG. 9A.

It is to be noted that mechanisms 40 and 420 may be positioned at anysuitable location along body portion 24 of structure 400.

As shown, the annuloplasty structure of implant structure 400 defines asubstantially ring-shaped configuration, e.g., a “D”-shapedconfiguration, as shown, which conforms to the shape of the annulus of amitral valve of the subject. For applications in which structure 400 isimplanted at a tricuspid valve of the patient, the annuloplastystructure assumes a shape suitable to fit the tricuspid valve (e.g., asubstantially oval shape).

It is to be noted that structure 400 is shown independently offlexible-longitudinal-tension-member-adjusting-mechanisms 240 andtension members 60 by way of illustration and not limitation. For someapplications, structure 400 is coupled to one or more mechanisms 240.

Reference is now made to FIGS. 10A-B, which are schematic illustrationsof an implant structure 500 comprising an annuloplasty ring structureconfigured to transition between a substantially planar configuration(FIG. 10A) and a saddle-shaped configuration (FIG. 10B) in response torotation of two or more (e.g., three, as shown)flexible-longitudinal-contracting-member-adjusting-mechanisms 40. Asshown, structure 500 comprises three adjusting mechanisms 40 a, 40 b,and 40 c that are aligned with the body portion of structure 500 along alongitudinal axis thereof, as described hereinabove with reference toFIG. 1. Adjusting mechanisms 40 a, 40 b, and 40 c are describedhereinabove with reference to FIGS. 1 and 3. It is to be noted, however,that the adjusting mechanisms may comprise adjusting mechanisms 240, asdescribed hereinabove with reference to FIGS. 1 and 4.

Structure 500 defines an anterior-configured portion 502, aposterior-configured portion 508, and first and second commissuralportions 504 and 506, respectively. Typically, one or more flexiblelongitudinal contracting members (e.g., contracting member 30, asdescribed herein) is disposed within the lumen of the body portion ofstructure 500. For some applications the number of contracting membersdisposed within the lumen of structure 500 corresponds to the number ofadjusting mechanisms 40 coupled to structure 500.

In response to rotation of the rotatable structures of adjustingmechanisms 40 a, 40 b, and 40 c in first rotational directions, the oneor more contracting members are pulled tight (e.g., in response towinding successive portions of the one or more contracting membersaround the respective rotational structures of adjusting mechanisms 40a, 40 b, and 40 c). Responsively, anterior-configured portion 502 andposterior-configured portion 508 are pulled upward, and first and secondcommissural portions 504 and 506 are pulled downward, in the directionas indicated by the arrows, such that structure 500 assumes asaddle-shape (as shown in FIG. 10B).

It is to be noted that the rotation of the rotational structure ofadjusting mechanisms 40 a, 40 b, and 40 c is reversible, and thatfollowing rotation of the rotatable structure in order to pull structure500 into the configuration shown in FIG. 10B, the rotatable structuremay be rotated in a second rotational direction that opposes the firstrotational direction in order for structure 500 to assume theconfiguration shown in FIG. 10A.

As shown, the annuloplasty structure of implant structure 500 defines asubstantially ring-shaped configuration, e.g., a “D”-shapedconfiguration, as shown, which conforms to the shape of the annulus of amitral valve of the subject. For applications in which structure 500 isimplanted at a tricuspid valve of the patient, the annuloplastystructure assumes a shape suitable to fit the tricuspid valve (e.g., asubstantially oval shape).

It is to be noted that structure 500 is shown independently offlexible-longitudinal-tension-member-adjusting-mechanisms 240 andtension members 60 by way of illustration and not limitation. For someapplications, structure 500 is coupled to one or more mechanisms 240.

It is to be noted that mechanisms 40 may be positioned at any suitablelocation along body portion 24 of structure 500. It is to be furthernoted that any suitable number of mechanisms 40 may be coupled tostructure 500.

Reference is made to FIG. 11. Following implantation of the implantstructures described herein, the implant structures may be adjustedwhile the patient is not on a cardiopulmonary bypass pump (i.e., “offpump”, e.g., while the heart of the patient is beating) (e.g., asdescribed hereinabove with reference to FIGS. 6A-B). Adjustment (e.g.,rotation) of the adjusting mechanisms off-pump facilitates adjustmentwhile monitoring heart and/or valve function, and/or blood flow usingimaging techniques, such as fluoroscopy and ultrasound (e.g., Dopplerultrasound), such that an operating physician 520 may adjust untiloptimal heart function and/or blood flow is attained. For example, andas shown in FIG. 11, two or more elongate rotation tools 522 (e.g.,elongate rotation tools 522 a, 522 b, and 522 c), configured to adjustrotate spool 46 and/or spool 246, may extend from outside of the body ofthe patient 524, to respective adjusting mechanisms of the implantstructure, such that operating physician 520 can adjust the adjustingmechanisms of the annuloplasty structure while monitoring a display 526that displays information indicative of the heart and/or valve functionand/or the blood flow.

The order in which the adjusting mechanisms are adjusted may be decidedby the physician, such as in response to the blood flow monitoring. Forexample, the operating physician may adjust adjusting mechanism 40, thenobserve display 526, then adjust one or more adjusting mechanisms 240.Alternatively, the physician may adjust one or more adjusting mechanisms240 first, and subsequently adjust adjusting mechanism 40. It will beunderstood by those familiar with the art, that any order of adjustmentis possible, and similarly, that display 526 may be monitoredsimultaneously with the adjustments, and/or between adjustments. It isto be noted that the scope of the invention includes other feedbacksystems, such as audio and/or tactile feedback, in addition to, orinstead of, display 526.

Reference is now made to FIGS. 1, 2B, 5, 6A-B, 7A-B, 8A-B, and 9A-B. Itis to be noted that the annuloplasty structures described herein may beshaped so as to define a saddle-shaped ring.

Reference is now made to FIGS. 1, 2B, 5, 6A-B, 7A-B, 8A-B, 9A-B, and10A-B. It is to be noted that for any implant structure describedherein, adjusting mechanism 240 may be used in place of adjustingmechanism 40, and adjusting mechanism 40 may be used in place ofadjusting mechanism 240, mutatis mutandis. As described hereinabove,adjusting mechanisms 40 and 240 are rotatable in first and secondopposing rotational directions (i.e., are bidirectionally rotatable),and are thereby configured to reversibly (1) tighten and loosen (e.g.,shorten and lengthen) flexible contracting member 30, and therebyreversibly expand and contract the annuloplasty structure, and (2)tighten and loosen tension member 60, and thereby reversibly reshapetissue of the ventricle. It is to be further noted that adjustingmechanisms 240 described herein may be provided together with orindependently of guide members 86.

Reference is again made to FIGS. 1, 2B, 5, 6A-B, 7A-B, 8A-B, 9A-B, and10A-B. It is to be noted that any suitable number offlexible-longitudinal-tension-member-adjusting-mechanisms 240 may becoupled to the annuloplasty structures of implant structures 122, 222,400 and 500. For some applications, only oneflexible-longitudinal-tension-member-adjusting-mechanism 240 is coupledto the annuloplasty structures of implant structures 122, 222, 400, and500. It is to be further noted that any suitable number of flexiblelongitudinal tension members 60 may be coupled to eachflexible-longitudinal-tension-member-adjusting-mechanism 240.

Reference is now made to FIGS. 1, 2B, 5, 6A-B, 7A-B, 8A-B, 9A-B, and10A-B. It is to be noted that although systems 300, 320, and 340 showimplant structure 122, it is to be noted that the scope of the presentinvention includes the implantation of implant structure 222, asdescribed hereinabove with reference to FIG. 5, implant structure 400,as described hereinabove with reference to FIGS. 9A-B, or implantstructure 500, as described hereinabove with reference to FIGS. 10A-B.Additionally, it is to be noted that adjusting mechanisms 240 a and 240b are shown as being disposed in the vicinities of respective fibroustrigones 8 and 10 by way of illustration and not limitation, and thatmechanisms 240 a and 240 b may be positioned at anywhere along the bodyportion of the annuloplasty structure of implant structure 122. Forexample, mechanisms 240 a and 240 b may be sutured to the body portionprior to delivery of structure 122. Alternatively, mechanisms 240 a and240 b are coupled to respective rings 241 (as described hereinabove withreference to FIGS. 2A-B), and mechanisms 240 a and 240 b are slid todesired locations along the body portion of the annuloplasty structure.It is to be further noted that housing 44 (and mechanism 40) may bedisposed at any suitable location along structure 122, and not only inthe portion of structure 122 configured to be disposed at the anteriorsection 7 of valve 14.

It is to be noted that systems 120, 220, 300, 320, 340, and structures400 and 500 for repairing a dilated annulus of the subject may be usedto repair any cardiac valve of the subject, e.g., the mitral valve, thetricuspid valve, the aortic valve, and the pulmonary valve. It is to bestill further noted that systems described herein for treatment ofvalves may be used to treat other annular muscles within the body of thepatient. For example, the systems described herein may be used in orderto treat a sphincter muscle within a stomach of the subject.

Typically, the annuloplasty ring structures described herein, theadjusting mechanisms, and the flexible longitudinal members are advancedand implanted in an open-heart procedure. For some applications, devicesdescribed herein may be implanted using a minimally-invasive orpercutaneous transcatheter procedure.

Additionally, the scope of the present invention includes applicationsdescribed in one or more of the following:

-   -   U.S. patent application Ser. No. 12/435,291 to Maisano et al.,        entitled, “Adjustable repair chords and spool mechanism        therefor,” filed on May 4, 2009, which published as US Patent        Application Publication 2010/0161041, and which issued as U.S.        Pat. No. 8,147,542;    -   U.S. patent application Ser. No. 12/437,103 to Zipory et al.,        entitled, “Annuloplasty ring with intra-ring anchoring,” filed        on May 7, 2009, which published as US Patent Application        Publication 2010/0286767, and which issued as U.S. Pat. No.        8,715,342;    -   U.S. patent application Ser. No. 12/548,991 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed on        Aug. 27, 2009, which published as US Patent Application        Publication 2010/0161042, and which issued as U.S. Pat. No.        8,808,368;    -   PCT Patent Application PCT/IL2009/001209 to Cabiri et al.,        entitled, “Adjustable annuloplasty devices and mechanisms        therefor,” filed on Dec. 22, 2009, which published as PCT        Publication WO 10/073246;    -   PCT Patent Application PCT/IL2010/000357 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed on        May 4, 2010, which published as WO 10/128502; and/or    -   PCT Patent Application PCT/IL2010/000358 to Zipory et al.,        entitled, “Deployment techniques for annuloplasty ring and        over-wire rotation tool,” filed on May 4, 2010, which published        as WO 10/128503.

All of these applications are incorporated herein by reference.Techniques described herein can be practiced in combination withtechniques described in one or more of these applications.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

The invention claimed is:
 1. A method for use with an implant structure,a first tool, a second tool, and a longitudinal guide member, theimplant structure including (i) a body portion, (ii) a firstimplant-adjustment mechanism coupled to the body portion and configuredto adjust the implant structure, and (iii) a second implant-adjustmentmechanism coupled to the body portion, the method comprising: deliveringthe implant structure to a heart of a subject while the firstimplant-adjustment mechanism is coupled to the first tool, and thesecond implant-adjustment mechanism is coupled to the longitudinal guidemember; subsequently, coupling the implant structure to tissue of theheart; and subsequently, advancing the second tool along thelongitudinal guide member to the second implant-adjustment mechanism,the second tool configured to actuate the second implant-adjustmentmechanism.
 2. The method according to claim 1, wherein delivering theimplant structure to the heart comprises delivering the implantstructure to the heart using the first tool.
 3. The method according toclaim 1, wherein coupling the implant structure to the tissue comprisessuturing the implant structure to the tissue.
 4. The method according toclaim 1, further comprising, subsequently to coupling the implantstructure to the tissue, adjusting a first dimension of the implantstructure using the first tool, and adjusting a second dimension of theimplant structure using the second tool.
 5. The method according toclaim 4, wherein the first implant-adjustment mechanism includes a firstspool, and wherein adjusting the first dimension comprises adjusting thefirst dimension by rotating the first spool using the first tool.
 6. Themethod according to claim 5, wherein the second implant-adjustmentmechanism includes a second spool, and wherein adjusting the seconddimension comprises adjusting the second dimension by rotating thesecond spool using the second tool.
 7. The method according to claim 1,wherein the body portion includes an annuloplasty structure that iscoupled to the first adjustment mechanism and to the second adjustmentmechanism, and wherein coupling the body portion to the tissue comprisescoupling the annuloplasty structure to a valve annulus of the heart. 8.The method according to claim 7, wherein delivering the implantstructure to the heart comprises delivering the implant structure to theheart while the annuloplasty structure is coupled to an annuloplastysizer.
 9. The method according to claim 8, further comprising, prior todelivering the implant structure, contracting the annuloplasty structurearound the sizer using the first tool.
 10. The method according to claim7, wherein: the annuloplasty structure has a perimeter, and the methodfurther comprises, subsequently to coupling the annuloplasty structureto the valve annulus, contracting the perimeter by adjusting the firstimplant-adjustment mechanism using the first tool.
 11. The methodaccording to claim 10, further comprising, subsequently to coupling theannuloplasty structure to the valve annulus, adjusting the secondimplant-adjustment mechanism using the second tool.
 12. The methodaccording to claim 11, wherein the implant structure further includes aflexible longitudinal tension member, a first end portion of the tensionmember being coupled to the second adjustment mechanism, and whereincoupling the implant structure to the tissue further comprises couplinga second end portion of the tension member to tissue of a ventricle ofthe heart.
 13. The method according to claim 12, wherein coupling thesecond end portion of the tension member to the tissue of the ventriclecomprises coupling the second end portion of the tension member to apapillary muscle of the heart.
 14. The method according to claim 12,wherein the implant structure includes a tissue anchor coupled to thesecond end portion of the tension member, and wherein coupling thesecond end portion of the tension member to the tissue of the ventriclecomprises anchoring the second end portion of the tension member to thetissue of the ventricle using the tissue anchor.
 15. The methodaccording to claim 12, wherein adjusting the second adjustment mechanismcomprises, subsequently to coupling the second end portion of thetension member to the tissue of the ventricle, drawing the tissue of theventricle toward the annuloplasty structure by tensioning the tensionmember by adjusting the second adjustment mechanism.
 16. The methodaccording to claim 1, further comprising: subsequently to coupling theimplant to the tissue, actuating the first implant-adjustment mechanismusing the first tool, and subsequently to advancing the second toolalong the longitudinal guide member to the second implant-adjustmentmechanism, actuating the second implant-adjustment mechanism using thesecond tool.
 17. A method for use with an implant structure, a firsttool, a second tool, and a longitudinal guide member, the implantstructure including (i) an annuloplasty structure, (ii) a firstimplant-adjustment mechanism coupled to the annuloplasty structure, and(iii) a second implant-adjustment mechanism coupled to the annuloplastystructure, the method comprising: delivering the implant structure to aheart of a subject while the first tool is coupled to the firstadjustment mechanism, and the longitudinal guide member is coupled tothe second adjustment mechanism; subsequently, coupling the annuloplastystructure to a valve annulus of the heart such that the annuloplastystructure has a perimeter; and subsequently: contracting the perimeterby adjusting the first adjustment mechanism using the first tool;advancing the second tool along the longitudinal guide member to thesecond adjustment mechanism; and adjusting the second adjustmentmechanism using the second tool.
 18. The method according to claim 17,wherein the implant structure further includes a flexible longitudinaltension member, a first end portion of the tension member being coupledto the second adjustment mechanism, and wherein coupling the implantstructure to the tissue further comprises coupling a second end portionof the tension member to tissue of a ventricle of the heart.
 19. Themethod according to claim 18, wherein coupling the second end portion ofthe tension member to the tissue of the ventricle comprises coupling thesecond end portion of the tension member to a papillary muscle of theheart.
 20. The method according to claim 18, wherein the implantstructure includes a tissue anchor coupled to the second end portion ofthe tension member, and wherein coupling the second end portion of thetension member to the tissue of the ventricle comprises anchoring thesecond end portion of the tension member to the tissue of the ventricleusing the tissue anchor.
 21. The method according to claim 18, whereinadjusting the second adjustment mechanism comprises, subsequently tocoupling the second end portion of the tension member to the tissue ofthe ventricle, drawing the tissue of the ventricle toward theannuloplasty structure by tensioning the tension member by adjusting thesecond adjustment mechanism.
 22. A method for use with an implantstructure, a first tool, a second tool, and a longitudinal guide member,the method comprising: delivering the implant structure to a heart of asubject, the implant structure including: (i) a first adjustmentmechanism to which the first tool is coupled, and (ii) a secondadjustment mechanism to which the longitudinal guide member is coupled;subsequently, coupling the implant structure to tissue of the heart;subsequently to coupling the implant structure to the tissue, adjustinga first dimension of the implant structure using the first tool, whereinthe first adjustment mechanism includes a first spool, and whereinadjusting the first dimension comprises adjusting the first dimension byrotating the first spool using the first tool; advancing the second toolalong the longitudinal guide member to the second adjustment mechanismand adjusting a second dimension of the implant structure using thesecond tool, wherein the second adjustment mechanism includes a secondspool, and wherein adjusting the second dimension comprises adjustingthe second dimension by rotating the second spool using the second tool.